Global Utilization And Registry Database for Improved heArt preservatioN
Public ClinicalTrials.gov record NCT04141605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Global Utilization and Registry Database for Improved Heart Preservation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method. CONCERT DCD is a substudy designed to assess the safety and feasibility of a direct procurement method for donation after circulatory death (DCD) heart procurement (CONCERT DCD) that utilizes preservation in a SherpaPak Cardiac Transport System. This DCD Substudy will be limited to approved GUARDIAN-Heart Registry sites who have been qualified to participate. The DCD Substudy will include prospective recipient identification and documentation of informed consent.
Study identification
- NCT ID
- NCT04141605
- Recruitment status
- Enrolling by invitation
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 4,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2020 (Actual)
- Primary completion
- Dec 31, 2028 (Estimated)
- Completion
- Dec 31, 2029 (Estimated)
- Last update posted
- Oct 16, 2026
2020 – 2029
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | — |
| Medstar Washington Hospital | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Health Shands Hospital | Gainesville | Florida | 32608 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Lutheran Hospital | Fort Wayne | Indiana | 46804 | — |
| Kansas University Medical Center | Lawrence | Kansas | 66045 | — |
| Tufts University Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| NewYork-Presbyterian Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Duke University | Durham | North Carolina | 27708 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Pennslyvania State University | State College | Pennsylvania | 16801 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Sentara Healthcare | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04141605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04141605 live on ClinicalTrials.gov.